Clinical Trial and Post-marketing Data: Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Infections and Infestations: Very rare: Opportunistic infection.
Immune System Disorders: Very rare: Local hypersensitivity.
Endocrine Disorders: Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression: (see also Skin and Subcutaneous Tissue Disorders as follows) Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, local skin burning/pain of skin. Very rare: Allergic contact dermatitis/dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy* skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, alopecia*. trichorrhexis*.
General Disorders and Administration Site Conditions: Very rare: Application site irritation/pain.
*Skin features of hypothalamic-pituitary-adrenal (HPA) axis suppression.